Aegerion Pharmaceuticals disclosed today that it is being investigated by the US Department of Justice over its marketing of Juxtapid (lomitapide). The drug was approved in December 2012 to help further lower cholesterol in patients with homozygous familial hypercholesterolemia. The drug costs $250,000 a year. The approval came with a box warning about the risk of hepatotoxicity and a strict Risk Evaluation…
Justice Department Investigating Aegerion Over Marketing Of New Cholesterol Drug
January 9, 2014 by Leave a Comment
Unconventional Analysis Finds Threshold For LDL Reduction With Statins
April 29, 2013 by Leave a Comment
Using an unconventional mathematical approach, a group of Japanese researchers say there may be no good reason to reduce LDL cholesterol more than 40 mg/dl. Their research letter has been published online in JAMA Internal Medicine. According to the authors, members of the ALICE (All-Literature Investigation of Cardiovascular Evidence) Group, most meta-analyses use linear models…
CHMP Recommends Against Approval For Mipomersen In Europe
December 14, 2012 by Leave a Comment
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency today recommended that mipomersen (Kynamro, Isis and Genzyme) not be approved for use in Europe. The novel antisense oligonucleotide works by inhibiting the synthesis of apo-B and is under development in the United States and Europe for the treatment of familial hypercholesterolemia….
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